Clinical Development Medical Director, (MD Required)

Job description

The Clinical Development Medical Director, (MD Required) is responsible for medical and scientific oversight, data integrity, and quality of clinical trials in Internal Medicine, with direct responsibility for clinical deliverables for one or more studies. They may also manage, supervise, and mentor others. JOB RESPONSIBILITIES: Provides medical monitoring on one or more clinical trials: Provides timely, study-related medical information and guidance, e.g., on: Medical questions from investigator sites Medical issues in clinical trial data Medical findings in audits or inspections Contributes to medical assessments of Quality Events Conducts and documents periodic safety data review and ongoing clinical/medical data review Reviews Required Safety Text for the Informed Consent Document and significant medical changes in the Informed Consent Document May independently lead clinical execution of one or more studies; may be accountable for program level clinical deliverables May provide input to the protocol design document; leads development of the protocol, including protocol amendments, Protocol Administrative Change Letters, and Dear Investigator Letters Represents the study team i...